Amended regulations regarding the reporting of adverse drug reactions came into force on February 10, 2011.1 The objective of the amended regulations is to strengthen the current adverse drug reaction reporting section of the Food and Drug Regulations in order to permit more rigorous monitoring of the safety of drug products by the Minister of Health.

Under the regulations as they were before the amendments came into force, drug manufacturers were required to submit a case report to the Minister within 15 days of becoming aware of any serious adverse reaction associated with a drug. Manufacturers were also required to prepare annual summary reports on adverse drug reactions but were not compelled to provide these reports unless the Minister, after reviewing a manufacturer's case report, first decided that a particular drug may not be safe.

The amended regulations will now require all drug manufacturers to immediately notify the Minister in writing if they determine, while preparing their annual summary reports, that a significant change has taken place in what was known about the risks and benefits of the drug during the period covered by the report being prepared. The Minister may, on the basis of this notification, request the manufacturer to submit the annual summary report and/or the adverse drug reaction case reports. The manufacturer must comply with this request within a reasonable specified period, determined only after the manufacturer has been provided with an opportunity to be heard regarding the submission period.

Note that a drug manufacturer that has already notified the Minister of a significant change in the risks and benefits of a drug will not have to again notify the Minister regarding the same issue.

The amended regulations also permit the Minister to request an annual summary and adverse drug reaction case report whenever he or she decides to examine the safety and effectiveness of the drug. As in the case of a notification-based request, the Minister requires the report to be submitted within a specified and reasonable time; however, if the information is required in order to determine whether a drug poses a serious and imminent risk to human health, the Minister may specify a shorter period than 30 days.

Drug manufacturers are now also required to retain records of the summary reports and adverse drug reaction cases for 25 years from the date the record was created, instead of the previously indefinite retention period, in order to provide sufficient time to develop a safety profile of drugs made available to Canadians.

The amended regulations do not indicate whether the Minister will publish the manufacturers' reports or summaries on the Health Canada website. Presumably, the reports may be subject to access requests via the Access to Information Act regime.

In the United States, drug manufacturers must submit annual reports to the Food and Drug Administration (FDA) containing a "brief summary of significant new information from the previous year that might affect the safety, effectiveness or labelling of the drug product."2 This is quite different from the standard imposed by the amended regulations, which require more frequent and timely reporting in Canada (it is expected that an average of 10-15 reports would occur per year).

Note that proposed amendments to the U.S. regulations would require manufacturers to notify the FDA of safety findings as they occur. As the Canadian amended regulations have come into force before any amendments to the U.S. regulations, there may be significant implications for the pharmaceutical industry. First, Health Canada may become aware of safety issues before the FDA does, and so may attempt to drive corrective action. Second, the fact that a Canadian manufacturer has reported a "significant change" in the known risks and benefits of a drug may be alleged to be an admission regarding safety in the context of product liability litigation. This could spur class action suits regarding drugs that have been the subject of Canadian adverse event reports.

The process for drug manufacturers to notify the Minister according to the amended regulations will be clarified in guidance documents issued by Health Canada, and Health Canada's standard operating procedures for receiving and reviewing case and summary reports will be altered to allow receipt of the notifications now required under the amended regulations.

Footnotes

1 Regulations Amending the Food and Drug Regulations (Adverse Drug Reaction Reporting), C. Gaz. 2011.II. 460, March 2, 2011.

2 Ibid. at 464-465.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific advice should be sought about your specific circumstances.